FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
FDA
The first article provides an overview of the guidance document dedicated to the human factors and the way they should be considered when developing user interfaces for medical devices. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The present article describes the aspects related to material characterization, removing manufacturing material residues, and sterilization. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
FDA
The first article provides an overview of the regulatory background for the patient-reported outcome instruments when evaluating the safety and effectiveness of medical devices, and also highlights the most important aspects to be considered in this respect. ...
FDA
The third in our series covering FDA guidance on additive manufactured medical devices, the present article addresses matters related to the design and manufacturing process, including those related to connections between the additive manufacturing technology used,...
